DXI800全自动化学发光免疫分析仪测定肿瘤标志物的性能验证  

Analytical performance verification of DxI 800 automated chemiluminescence analyzer in detecting The tumor markers ABSTRACT

作　　者：齐文峰 齐永志[2] 奚凌云 QI Wenfeng;QI Yongzhi;XI Lingyun(Department of Clinical Laboratory,Outpatient Department of the Navy,Beijing100036,China;Department of Clinical Laboratory,Navy General Hospital,Beijing 100048,China;Department of Clinical Laboratory,the 252 Hospital of PLA,Baoding,Hebei 071000,China)

机构地区：[1]海军机关门诊部检验科,北京100036 [2]海军总医院检验科,北京100048 [3]解放军二五二医院检验科,河北保定071000

出　　处：《国际检验医学杂志》2018年第A01期78-81,共4页International Journal of Laboratory Medicine

摘　　要：目的 验证和评价贝克曼DXI800检测甲胎蛋白（AFP）、癌胚抗原（CEA）、总前列腺抗原（T-PSA）、游离前列腺抗原（f-PSA）、糖类抗原125（CA125）、糖类抗原153（CA153）、糖类抗原199（CA199）的方法学性能。 方法 参照美国临床和实验室标准协会（CLSI）的相关文件，对肿瘤标志物AFP、CEA、T-PSA、f-PSA、CA125、CA153、CA199的正确度、精密度、线性、可稀释倍数、参考区间进行验证。参考临检中心室间质量评价相关质量目标，验证合格的标准为，平均偏倚小于12.5%；批内不精密度小于6.25%，批间不精密度小于8.33%；线性范围验证斜率（a）在0.975~1.025以内，相关系数R＞0.975；可稀释倍数，回收率在80％≤R≤120%；参考区间符合率≥95%。 结果 DXI800上7项肿瘤标志物检测各项性能参数达到质量目标规定，性能验证合格。 结论 贝克曼DXI800全自动化学发光免疫分析仪检测7项肿瘤标志物方法学性能满意，结果可靠，能满足临床需要。Objective ： To verification and evaluation the methodology performance of BECKMAN DXI800 detecting AFP（AFP）,carcinoembryonic antigen（CEA）,total prostate antigen（T-PSA）,free prostate antigen（f-PSA）,carbohydrate antigen 125（CA125）,carbohydrate antigen 153（CA153） and carbohydrate antigen 199（CA199）. Methods ： According to the American Clinical and Laboratory Standards Institute（CLSI） of the relevant documents,the accuracy,precision,linearity,reference range and lower limit of the detection of the BECKMAN DXI 800 in detecting the tumor markers AFP,CEA,T-PSA,f-PSA,CA125,CA153 and CA199 were detected.The standard for validation is based on the quality objective of external quality assessment in the inspection center.Average bias is less than 12.5%.The intra-inaccuracy of the batch was less than 6.25%,and the inter-inaccuracy of the batch was less than 8.33%.The linear range verification slope a value is within 0.975-1.025 and correlation coefficient R value is more than 0.975.The recovery rate R is with in 80%-120%;The conformity rate of reference interval is greater than 95%. Results The performance parameters of DXI800 in detecting 7 tumor markers meet the quality objectives,and the performance verification was qualified. Conclusion： The methodology performance and results of the BECKMAN DxI 800 automated chemiluminescence analyzer system in detecting 7 tumor markers to be reliable and satisfied,can meet clinical needs.

关 键 词：化学发光 肿瘤标志物 性能验证 

分 类 号：R581[医药卫生—内分泌]